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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER JMINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS
RULE §229.148State Operational Requirements

    (H) Immuno-suppressed populations shall be evaluated periodically as indicated to rule out active tuberculosis, particularly after contact with persons known to be infectious. HIV-infected persons with a positive tuberculin skin test (equal to or greater than 5 mm of indurations) should have a chest x-ray and be evaluated by a clinician to rule out active tuberculosis. HIV-infected individuals who have symptoms suggestive of tuberculosis shall be referred for chest x-ray and clinical evaluation regardless of their tuberculin skin test status.

  (10) Minimum required laboratory tests. All biological samples must be analyzed by a laboratory approved under the Clinical Laboratory Improvement Amendments (CLIA) and all applicable Texas state standards. For those tests requiring a blood sample, if in the reasonable clinical judgment of the program physician, a patient's subcutaneous veins are severely damaged to the extent that a blood specimen cannot be obtained, the lab tests may be omitted; however, an attempt to perform the required laboratory tests must be made annually or the patient must be referred to a medical facility that is able to draw blood. The following tests must be performed and documented:

    (A) CBC and differential;

    (B) routine and microscopic urinalysis;

    (C) liver functions profile (SGOT, SGPT); and

    (D) serological test for syphilis.

  (11) Short-term detoxification. A patient may be admitted to short-term detoxification regardless of age. The program physician shall document in the patient record the reason for admitting the patient to short-term detoxification. Take-home medication is not allowed during short-term detoxification. A history of one year opiate dependence is not required for admission to short-term detoxification. No test or analysis is required except for the initial drug screening test, and a tuberculin skin test. The initial treatment plan and periodic treatment plan evaluation required for comprehensive maintenance patients are not necessary for short-term detoxification patients. A primary counselor must be assigned by the program to monitor a patient's progress toward the goal of short-term detoxification and possible drug-free treatment referral. The narcotic drug is required to be administered daily by an agent authorized by the physician in reducing doses to reach a drug-free state over a period not to exceed 30 days. All other requirements of comprehensive maintenance treatment shall apply.

  (12) Long-term detoxification. A patient may be admitted to long-term detoxification regardless of age. The narcotic drug is required to be administered daily in reducing doses to reach a drug-free state over a period not to exceed 180 days. The patient is required to be under observation while ingesting the drug at least six days a week. Initial and random monthly drug screening tests must be performed on each patient. Initial and monthly treatment plans are required. All other requirements of comprehensive maintenance treatment shall apply.

  (13) Denial of admission. If in the reasonable clinical judgment of the medical director a particular patient would not benefit from treatment with a narcotic drug, the patient may be refused such treatment even if the patient meets the admission standards.

(f) Treatment planning.

  (1) Initial treatment plan. The primary counselor shall enter in the patient's record the counselor's name, the contents of the patient's initial assessment, and the initial treatment plan. The primary counselor shall make these entries immediately after the patient is stabilized on a dose or within four weeks after admission, whichever is sooner. The initial treatment plan is required to contain a statement that outlines:

    (A) realistic short-term treatment goals which are mutually acceptable to the patient and the program;

    (B) behavioral tasks a patient must perform to complete each short-term goal;

    (C) the patient's requirements for education, vocational rehabilitation, and employment;

    (D) the medical psychosocial, economic, legal, or other supportive services that a patient needs;

    (E) the frequency with which these services are to be provided and/or the source to which the patient will be referred to receive the necessary services; and

    (F) the treatment plan must be signed and dated by the primary counselor and the patient.

  (2) Periodic treatment planning. The program physician or primary counselor shall review, reevaluate, and alter where necessary each patient's treatment plan at least once each 90 days during the first year of treatment, and at least twice a year thereafter. The treatment plan must be signed and dated by the primary counselor and the patient. At least once a year, the program physician shall review the treatment plan documented in each patient's record, and ensure that each patient's progress or lack of progress in achieving the treatment goals is entered in the patient's record by the primary counselor.

  (3) The program supervisory counselor or physician shall review and countersign all treatment plans formulated by counselor interns.

  (4) Counseling sessions. Frequency and content of counseling sessions with patients shall be in keeping with patient needs and modality of treatment.

(g) Approved narcotic drugs.

  (1) Methadone. The program medical director or program physician shall prescribe methadone in accordance with 42 CFR, §8.12(h)(3-4). If opiate abstinence symptoms are not suppressed, the physician may administer additional methadone, within a scope that ensures patient safety, and taking into consideration the pharmacokinetic properties of the methadone. The medical director shall take into consideration the drug manufacturer's dosing instructions and current best practices when prescribing and administering. Methadone shall be administered or dispensed in oral form only when used in an outpatient treatment program. Hospitalized patients under care for a medical or surgical condition are permitted to receive methadone in parenteral form when the attending physician judges it advisable. All forms of methadone shall be dispensed in such a way as to reduce its potential for parenteral abuse and to differentiate it from other narcotic drugs (i.e., contrasting color and taste), unless prior SMA approval is obtained.

  (2) Levo-alpha acetyl methadol (LAAM). The program medical director shall prescribe LAAM in accordance with drug manufacturer's dosing instructions and current best practices.

  (3) A narcotic drug may be administered or dispensed only by an agent of the practitioner. The licensed practitioner assumes responsibility for the amounts of narcotic drugs administered or dispensed and shall record and countersign all changes in dosage schedules. If the program keeps the record of administration and dispensing of narcotic drugs separate from the patient's file, the program shall transfer data from the dosing record to the patient's file at least monthly.

(h) Testing for licit and illicit drug use. The physician shall ensure that test results are not used as the sole criterion to force a patient out of treatment, but are used as a guide to change treatment approaches. The program shall ensure that when test results are used, presumptive laboratory results are distinguished from results that are definitive.

  (1) Drug abuse tests. Analysis of such tests shall be performed in a laboratory approved under the Clinical Laboratory Improvement Amendments (CLIA) and all applicable Texas state standards.

    (A) The program shall ensure that an initial drug test or analysis is performed for each new patient, including permanent transfer patients, before the initial or maintenance dose is administered, and at least monthly random tests or analyses are performed on each patient in comprehensive maintenance treatment for the initial year of treatment and eight random drug abuse tests yearly thereafter. When a sample is collected from each patient for such test or analysis, it must be done in a manner that minimizes opportunity for falsification.

    (B) The program must have and follow written procedures for the screening of test samples for licit and illicit drugs. The procedures shall describe in sufficient detail a plan for collection, storage, handling and analysis of test samples. The procedures shall further describe the program's response to test results that include at least the following:

      (i) training for staff members of the importance and relevance of reliable and timely drug abuse test procedures and reports, the purpose of conducting drug abuse tests, and the significance of the results;

      (ii) a protocol for collection of test samples that minimizes the opportunity for falsification and incorporates the elements of randomness and surprise;

      (iii) storage of test samples in a secure place to avoid substitution;

      (iv) a requirement for disclosure of test sample results to the patient and documentation in the patient record of program and patient response to the test results; and

Cont'd...

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